XGEVA

Card Set Information

Author:
darbyh
ID:
51221
Filename:
XGEVA
Updated:
2010-11-22 19:59:02
Tags:
PI
Folders:

Description:
product info
Show Answers:

Home > Flashcards > Print Preview

The flashcards below were created by user darbyh on FreezingBlue Flashcards. What would you like to do?


  1. Indication
    Prevention of SREs in patients with bone mets from solid tumors
  2. Limitation of use
    Not indicated for pts with bone mets from multiple myeloma
  3. Dosage and Admin
    120 mg every 4 weeks as SQ injection in upper arm, upper thigh or abdomen
  4. dosage forms and strengths
    120 mg/ 1.7 mg/mL single use vial
  5. Contraindications
    NONE
  6. Warnings and Precautions
    • Hypocalcemia
    • Osteonecrosis of the Jaw
  7. Warnings re: Hypocalcemia
    • Severe Hypocalcemia can occur. Corret hypocalcemia prior to initiating XGEVA. Monitor for Symptoms.
    • Monitor Ca levels and supplement with Ca and Vit D
  8. Warnings re: ONJ
    Perform an oral exam prior to starting XGEVA. Monitor for symptoms; Avoid invasive dental procedures during treatment.
  9. ADVERSE REACTIONS
    • Most common:
    • Fatigue/Astenia 45 vs 46
    • Hypophosphatemia 32 vs 20
    • Nausea 31 vs 32
  10. Serious AEs
    Dyspnea 21 vs 18
  11. Most common AEs leading to DC
    • Hypocalcemia 18 vs 9
    • ONJ 2.2 vs 1.3
  12. Special populations
    • Pregnancy: may cause fetal harm
    • Nursing: May impair mammary gland devt and lactation. d/c drug or nursing
    • Peds: Safety/effic not estab
    • Renal Impairment: cCl <30 or on dialysis are at risk for hypocalcemia. Suppl w ca or Vit D
  13. Safety was evaluated in ? randomized, ________, double-dummy trials in _________ patients with bone mets from ? cancer, ? cancer, or other solid tumors, or lytic bony lesions from ______.
    • 3
    • double-blind
    • 2841
    • prostate, breast
    • multiple myeloma
  14. Median duration XGEVA exposure was __ months
    12
  15. Of pts receiving XGEVA ___% were female, and ____% were white
    • 46
    • 85
  16. Exclusions for studies
    • IV bisphoshonates
    • Hx of ONJ or OMJ
    • active dental/jaw condition needing surgery
    • planned invasive dental procedure
  17. Other entry criteria
    • cCL 30 mL/min or more
    • Corr Ca 8-11.5 mg/dL
  18. incidence of severe hypocalcemia (less than 7) occurred in ___ of XGEVA patients and ___ of zoledronic acid tx'd patients
    • 3.1
    • 1.3%
    • ( OF THOSE 33% had 2+ episodes, 16% had 3+ episodes)
  19. ONJ in 3 studies was confirmed in ___ of patients with XGEVA and ___ with zoledronic acid.
    • 1.8
    • 1.3
    • extended treatment phase of 4 months= 2.2% with XGEVA
  20. What color is XGEVA
    clear, colorless to pale yellow
  21. Storage of XGEVA
    2-8 degrees C (36-46F) in original carton. Do not freeze. Upon removal from fridge, keep under 77 degrees, do not expose to light, use within 14 days.
  22. Avoid _____ _____ of XGEVA
    vigorous shaking
  23. Advise patients to contact HCP for:
    • Symptoms of Hypocalcemia
    • Symptoms of ONJ
    • Persistent pain or slow healing of mouth
    • Pregnancy or nursing
  24. Advise pts of need for:
    • Proper oral hygeine and routine dental care
    • Informing dentist they take XGEVA
    • Avoiding dental procedures while taking XGEVA
    • Also that marketed as PROLIA.
  25. Description: XGEVA is a ____ ____ mab that binds to human ____
    • human IgG2
    • RANKL
  26. pH of XGEVA
    5.2
  27. RANKL is a ________or soluble _____ essential for ______, _____, and ____ of ______, the cells responsible for bone resorption.
    • transmembrane
    • formation, function, and survival
    • osteoclasts
  28. Increased ______ ______, stimulated by RANKL is a mediator of bone _____ in solid tumors with osseous ______.
    • osteoclast activity
    • pathology
    • mestastases
  29. Possible effects of XGEVA in peds
    • may impair bone growth in children with open growth plates
    • may inhibit eruption of dentition
  30. DRUG interactions
    • NO formal
    • All patients were on concomitant chemo

What would you like to do?

Home > Flashcards > Print Preview